FDA.reportPublic FDA data

TriClip™

Primary DI
05415067047755
Brand
TriClip™
Company
ST. JUDE MEDICAL, INC.
Model
TCDS0301-XTW
Catalog number
TCDS0301-XTW
Device description
G4 Delivery System
Published
2024-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPSTricuspid valve repair device, percutaneously delivered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPSTricuspid Valve Repair Device, Percutaneously DeliveredUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230007000TriClip G4 SystemABBOTT MEDICAL2024-04-01NPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067047755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067047755054150670477555415067047755

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve clipAn implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous clip delivery system (CDS) guided by echocardiographic and fluoroscopic imaging. It is typically made of implant grade metal alloys with a polyester fabric cover. Disposable devices associated with implantation (e.g., CDS and accessories) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth6Millimeter
Length12Millimeter
Width22Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067032195EnSite™ENSITE-FF-01ENSITE-FF-012021-01-06
05415067032201EnSite™ENSITE-R-FF-01ENSITE-R-FF-012021-01-06
05415067024732EnSite Precision™H702473H7024732020-07-22
05415067024695EnSite Precision™H702469H7024692016-12-20
05415067024701EnSite Precision™H702470H7024702016-12-20
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067054463Ampere™AMP-TFDM-01AMP-TFDM-012026-08-19
05415067054661TactiSys™TSQ-V1.8-TFDM-01TSQ-V1.8-TFDM-012026-08-19
05415067055651EnSite™ENSITE-D-FOCAL-01ENSITE-D-FOCAL-012026-08-19
05415067055668EnSite™ENSITE-D-PI-01ENSITE-D-PI-012026-08-19
05415067055675EnSite™ENSITE-PI-01ENSITE-PI-012026-08-19
05415067055682EnSite™ENSITE-FOCAL-01ENSITE-FOCAL-012026-08-19
05415067050724TriClip™TSGC0801TSGC08012025-12-11
05415067050908MitraClip™SGC0801SGC08012025-12-11
05415067051844Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-LSI-1371-L2025-02-07
05415067051851Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-MSI-1371-M2025-02-07
05415067050182Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-SSI-1371-S2024-08-15
05415067047748TriClip™TSGC0201TSGC02012024-04-12
05415067038487Aveir™LSCD201LSCD2012023-08-15
05415067036384Aveir™LSCD111LSCD1112023-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067050731TriClip™ST. JUDE MEDICAL, INC.NPS2025-12-11
05415067050816TriClip™ST. JUDE MEDICAL, INC.NPS2025-12-11
05415067050847TriClip™ST. JUDE MEDICAL, INC.NPS2025-12-11
05415067050885TriClip™ST. JUDE MEDICAL, INC.NPS2025-12-11
05415067047700TriClip™ST. JUDE MEDICAL, INC.NPS2024-04-12
05415067047724TriClip™ST. JUDE MEDICAL, INC.NPS2024-04-12
05415067047731TriClip™ST. JUDE MEDICAL, INC.NPS2024-04-12